Speeches & Floor Statements

Posted on November 29, 2016

Mr. President, tomorrow the U.S. House of Representatives will vote on a piece of legislation that many in this body on both sides of the aisle have worked on and that the Majority Leader of the Senate has described as the single most important piece of legislation that will pass this year. We call it the 21st Century Cures Act, and it includes three mental health reform acts—the most significant reforms in mental health programs in 10 years.

I ask unanimous consent to have printed in the Record at the conclusion of my remarks the more than 200 organizations from all across the country supporting the 21st Century Cures legislation.

Why would the Majority Leader say it is the most important legislation the Senate might act on—because we do a lot of important stuff around here, whether it is Defense authorization, whether it is cyber security, whether it is the bill to fix No Child Left Behind that we passed in a bipartisan way last December. I think it is because this legislation will affect virtually every American family because we are entering the most exciting period of medical research in our country. That is the first part of it.

The second part, which has to do with mental health, affects so many families. We know that about one out of every five adult Americans suffers from some form of mental illness. This concentrates a large amount of money we actually spend on mental health programs every year from the Federal Government and spends it in a more effective way to actually help people.

In the next few minutes, I would like to acquaint the Senate again with how we have gone about this and remind Senators of how many of us have had a hand in this legislation. It is a remarkable 2 years of work that has involved many, many, many hearings, dozens of meetings, and that has been done in a large committee of 22 Senators of very different points of view in a largely bipartisan way.

I will summarize. The first thing I would mention, the legislation includes $6.3 billion of funding and $1 billion of that is for state opioid grants. Whether it is Senator Whitehouse of Rhode Island or Senator Ayotte and Senator Portman, probably most Senators of this body have seen on the front pages of their newspapers the tragedies of opioid abuse. I know that is true in Tennessee. This bill helps in two ways. The most immediate way is to provide state grants—Federal dollars to go to states—over the next 2 years to help states fight opioid abuse.

The other way it helps, when we get to the part about 21st Century Cures, is that Dr. Francis Collins, head of the National Institutes of Health—Dr. Collins calls it the “National Institutes of Hope”—says that one of the groundbreaking discoveries we expect to happen in this country is a non-addictive pain medicine. The problem with opioids is, they are addictive. Now, people need it. If you have a back surgery or if you have terrible pain, opioids can help people. We know that, but it is addictive and it is causing problems. What if we had non-addictive pain medicine? So this bill helps that in two ways.

There is other funding in this legislation: $4.8 billion to the National Institutes of Health. The first 1.8 billion of that is for Cancer Moonshot. This is Vice President Biden's initiative. He is motivated for many reasons by it. His son died of cancer. Many of us have family members or friends with cancer. There are startling discoveries going on in cancer today. This is $1.8 billion in support of the Vice President's Cancer Moonshot.

Then there is $1.4 billion for the Precision Medicine Initiative. This is one of President Obama's most important initiatives. I know he has said that very realistically he expects it to happen anyway, but he would like to move it along. This helps move it along. What this means is that if the Senator from Oklahoma and I each have a disease, that because of our genetic background, the medicine we might get for that disease should be different. If we know that genetic difference between the two of us, the doctor can prescribe for it. That is called personalized medicine or precision medicine.

Then there is $1.6 billion for the BRAIN Initiative. This includes groundbreaking research in Alzheimer's, for example. I talked to one drug manufacturer that has spent more than $1 billion trying to develop a medicine that will help identify Alzheimer's before it shows symptoms and then another medicine that will slow the progression of Alzheimer's. Imagine what could happen in our country if, for the tens of millions of Americans who are going to suffer with Alzheimer's, we could find that out before they actually have the symptoms and we can then slow down the progression of Alzheimer's. Think of the suffering that would help avoid. Think of the billions of dollars it would save. This is for that kind of research. Dr. Collins says that during this next 10 years, he expects that we will be able to identify individuals at high risk for Alzheimer's before any symptoms appear and provide them with effective medicines to slow or prevent the disease.

It also includes $500 million for the Food and Drug Administration to help pay for the extra work we are giving the FDA.

One Senator was on the floor talking about this bill and suggested this isn't enough money. Let's talk about money just a minute. The United States spends more on biomedical research and development than Europe, Japan, and China—almost as much as those three put together. There has nevertheless been a real need for increased funding for the kinds of things I just mentioned, but the way we do things here is, we have authorization bills, which this is, where we decide what our policies and our programs are going to be. Some of us are on those committees—like the committee I chair, and of which Senator Murray of Washington is the ranking Democrat, the Health, Education, Labor, and Pensions Committee in this case. Then we have Appropriations Committees that decide how much we can afford to spend on that. We do that separately.

Last year, this Congress, a Republican majority, I would point out—but Senator Blunt, chairman of the Appropriations Committee for the Senate, would quickly give Senator Murray, the ranking Democrat, full credit—added $2 billion to the National Institutes of Health budget for 1 year. That means $20 billion over 10 years. This year, the same Republican Congress, with the cooperation of the Democratic Members, added another $2 billion to the National Institutes of Health budget. That is another $20 billion over 10 years. The Cures legislation that I have just described is another $5 billion. So that—20, 20 and 5—adds up to 45 billion new dollars approved. The first $20 billion is law, the second $20 billion has just been approved by the Appropriations Committees—hopefully it will become law—and the $5 billion I just described. Now, that is real money.

It is unusual to find an appropriations bill stuck on an authorization bill, but we have done it this time because this is an unusual opportunity, and we have done it in a way that Speaker Ryan and the House of Representatives believe is fiscally responsible. That means it doesn't add any new mandatory spending. That kind of spending has the budget going through the roof so it doesn't do that. It means it is paid for. That means we have reduced other spending to pay for it. When we look at the entire budget, it doesn't add a penny to the entire budget—we call it the discretionary plus the mandatory part—because it is paid for by reducing other spending.

We have set priorities, we have done our job, and the Appropriations Committee has done its job in consecutive years, approving $20 billion more over 10 years for the National Institutes of Health and will add another 5 here just to the National Institutes of Health.

Let's talk about the bipartisan nature of this bill. I am going to go through this fairly quickly, but for those watching, I think it is important to see this because sometimes when bills are popular—and I think this one will be popular. Everyone says: Well, that is easy. Tomorrow, the House of Representatives will vote on the 21st Century Cures bill. It includes the mental health bill—that I will describe in just a minute. I think it will be on suspension, which means they expect a big vote over there. I expect a big vote over here because I don't expect many Senators would want to vote no on a $1 billion grant program that will fight opioid abuse in their home state. I don't think there will be a lot of Senators who want to vote no on more money to fight cancer and to help the Vice President with the Cancer Moonshot. I suspect there will be a lot of Senators who want to vote yes to help the President advance his precision medicine legacy. I know there are families affected by Alzheimer's all over the country who hope Senators vote yes on the BRAIN Initiative. I imagine we will get a big vote when it comes up next Monday and Tuesday, after the House passes it tomorrow, but as we put this bill together, there was plenty of controversy, there was plenty of conflict, but virtually everything we did was bipartisan.

The money I just described is certainly bipartisan—the President's initiative, the Vice President's initiative, the opioid initiative. That is bipartisan, but look at the bills we are talking about.

Here is one called the Advanced Targeted Therapies, which allows researchers to use their own data from previously approved therapies to help find a faster treatment for serious genetic diseases—Senator Bennet, Democrat; Senator Warren, Democrat; Senator Burr, Republican; Senator Hatch, Republican—and it passed by voice vote.

I am very quickly going to go through 19 different bills that are the core of the 21st Century Cures legislation. They came out of our committee which has 22 Members, and the largest number of recorded votes against any one of those 19 bills was two because every single one of these bills had a Democratic sponsor and a Republican sponsor, except for one, and that was Senator Murray's bill, and she is the ranking Democrat on our committee. So don't let anyone suggest that a bill that has $6.3 billion of appropriations, that include Democratic priorities and bipartisan priorities, and the core of it is 19 bills of FDA and NIH reform that has a Democratic sponsor for every single bill and that was approved by a 22-member committee and only had two recorded votes against it—was the most that was against it—don't let anybody say this is not a bipartisan bill. Anyone who says that simply hasn't spent the time to be involved in the process.

Let's go to the next one.

Burr and Franken, Republican and Democrat, FDA Device Accountability. It will bring innovative devices like artificial knees and insulin pumps to patients more quickly by getting rid of unnecessary regulations.

One of the major things we need to do—and we do it in this bill—is to bring cures and discoveries through the regulatory process more quickly and at less cost. All of us are concerned about the price of drugs. One factor contributing to that cost is that it takes a billion dollars and 13 or 15 years to take a new discovery through the process. We would like to shorten that process as long as we can do it in a way that ensures that it is safe.

The next one is called the Next Generation Researchers Act—Senator Baldwin, Democrat; Senator Collins, Republican. It improves opportunities for our young researchers. It was passed by voice vote. That means there was no objection.

The next one is called the Enhancing Rehabilitation Research at the National Institutes of Health—Kirk, Republican; Bennet, Democrat; Hatch, Republican; Murkowski, Republican; Republicans Isakson and Collins, Enhancing Rehabilitation Research was passed by voice vote.

Neurological Diseases Research. Here we have Isakson and Murphy, Republican and Democrat, advancing Research for Neurological Diseases.

The next one has do with superbugs and protecting patients. You know about these. You get an infection, and you take a medicine to treat it, but the medicine doesn't work because the infection is a superbug. This bill will clarify that the FDA requires cleaning and validation data for reusable medical devices. In other words, this will make it less likely that will be a problem. That is Senator Murray's bill.

Improving Health IT. This is about electronic health records. The government has spent a huge amount of money on that, over $32 billion, including hospitals and doctors to adopt electronic medical records. It is very important to precision medicine, to personalized medicine, because if you can't use all this data, a doctor is not going to prescribe something for the Senator from Oklahoma that is different from something for the Senator from Tennessee.

We found that the electronic medical records system was a mess. We had six hearings on it, and we worked with the Obama administration because they could do some things to fix it and we could do some things to fix it. I thank Secretary Burwell in the Obama administration—I thank her and Andy Slavitt at CMS for the efforts they have made to do what they could do. And these are the things that we could do. Senator Murray was involved, Senator Cassidy, Senator Whitehouse, Senator Hatch, Senator Bennet. It was a bipartisan effort to reduce physician documentation burden—electronic health records to make it more interoperable and to get this system moving again.

Advancing Breakthrough Medical Devices. One of the great successes we have had in legislation was a few years ago when Senator Bennet and Senator Burr, among others, introduced a bill and made it law that brought breakthrough medicines through the Food and Drug Administration more rapidly. More than 49 have been approved and 464 requests for breakthrough designation in about 4 or 5 years. We are applying that same breakthrough strategy to medical devices. Of course, we have bipartisan support for that.

The Advancing Hope Act. If you are a parent of a child with a rare disease, such as brain cancer, this increases the opportunity that the drugs will help.

Medical Countermeasure Innovation Act. This is very important. Senators Burr and Casey have been real leaders in dealing with medical countermeasures. These are in case there is a bioterror attack, anthrax—some kind of man-made or naturally-occurring problem like that. Are we ready to deal with that? This helps to do that.

There are just a few more. Some will say: Why are you going on for so long? Because I would like for people to know when it happens that this Senate is capable of taking a great big, complex subject, and Democrats and Republicans are capable of working together to produce a result that deserves a big vote.

The Combination Products Innovation Act. This helps to bring to the market products that are made up of medical devices and medicines.

There is a bill by Wicker, Bennet, Collins, Klobuchar, Isakson, and Franken on Patient Focused Impact Assessment.

There is one to modernize the FDA workforce. Dr. Califf told us that his biggest problem at the FDA is that he can't hire all the people he needs to deal with all of the exciting things going on. This gives him new authority to do that. Everybody thinks that would be an important thing to do. It was approved by voice vote.

Advancing Precision Medicine. This is legislation that I introduced and supported the President's Precision Medicine Initiative, which I have talked about before.

There is other legislation that went through. The point of all of this is that 19 different bills are the core of this 21st Century Cures Act. The most recorded number of votes against this bill was two, and every single one was sponsored by a Democrat as well as a Republican, except for one, which was Senator Murray's bill. She is the ranking Democrat on the committee.

In conclusion, we are fortunate to be able to add to the bill the Mental Health Reform Act. Actually, we include three mental health bills, and together they make up the most significant reform of mental health programs that we have had in more than a decade. I want to give particular credit to Senator Murphy, Democrat, and to Senator Cassidy, Republican, for working together through some real landmines to get this to a place where it can pass the House almost unanimously and where it will be a part of the bill that we will vote on next week.

I want to thank the majority whip, Senator Cornyn, who also added an important judicial part to this legislation and helped us navigate some difficult issues. In other words, these Senators showed that they know how to legislate. They could have stood up and made a speech. They could have insisted on doing things exactly their way, but they said to look for the area where we might agree on 80 percent of the policy and let's agree that.

This is one of those bills. Look at the number of Republicans and Democrats who have passed that. Here is the second mental health bill we are talking about. You can see the number of Senators. I have taken some time to go through the legislation that will be coming to the Senate early next week and that will be voted on tomorrow in the House of Representatives. I do think it likely represents, as the Majority Leader has suggested, the most important piece of legislation that we could act on this year. Because it affects virtually every American family, Forbes magazine reported that 78 percent of the American people favored Congress taking action on medical innovation because they have heard people like Dr. Francis Collins, the head of the National Institutes of Health, talk about within the next 10 years having a Zika vaccine and HIV/AIDS vaccine, identifying Alzheimer's before symptoms appear and slow its progression, an artificial pancreas for those with diabetes, and a non-addictive type of pain medicine.

These are magnificent opportunities for us. We have strong leadership at the National Institutes of Health. We have put our money where our mouth is. It is true that we will have to approve it every year, and it is true that we had to reduce other spending in order to have this spending, but that is the way we are supposed to do things.

What we have done is take a bipartisan core of bills; we worked hard for two years in a bipartisan way and produced a result that had very few “no” votes along the way. It includes Democratic priorities as well as Republican priorities. It has the avid interest of the Democratic President of the United States, the Democratic Vice President of the United States. It is a part of the agenda forward in health care for the Republican Speaker of the House, and the Republican Majority Leader in the Senate says it is the most important bill we are going to act on.

I would think that would get a big vote tomorrow in the House, and I would think it deserves a big vote in the U.S. Senate next week. It has been my privilege to work with Senator Murray and the other members of the Committee on Health, Education, and Labor to produce the bill.